How You'll Make An Impact

• Ability to understand and follow institutional SOPs.  
• Review and assess protocol (including amendments) for clarity, logistical feasibility  
• Ensure that all training and study requirements are met prior to trial conduct.  
• Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.  
• Assist with planning and creation of appropriate recruitment materials.  
• Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.  
• Actively work with recruitment team in calling and recruiting subjects   
• Attend Investigator meetings as required.   
• Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.  
• Assist in the creation and review of source documents.  
• Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)  
• Study Management:  
  • Prioritize activities with specific regard to protocol timelines  
  • Maintain adherence to Health Canada Division 5 regulations and ICH guidelines in all aspects of conducting clinical trials.  
  • Maintain effective relationships with study participants and other care Access Research personnel.  
  • Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.  
  • Communicate clearly verbally and in writing.  
• Patient Coordination:  
  • Prescreen study candidates   
  • Obtain informed consent per Care Access Research SOP .  
  • Complete visit procedures in accordance with protocol.  
  • Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.  
  • Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.  
  • Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)  
• Documentation:  
  • Record data legibly and enter in real time on paper or e-source documents   
  • Accurately record study medication inventory, medication dispensation, and patient compliance.  
  • Resolve data management queries and correct source data within sponsor provided timelines  
  • Assist regulatory personnel with completion and filing of regulatory documents.  
• RN specific duties:  
  • Preparation and administration of Investigational Product (IP; study drug)  
  • Monitor participant for adverse reactions  
  • Communicate regularly with PI. 
  • Maintain a clean work area. 
  • Comply with Safety and PPE standards. 
  • Perform phlebotomy and insert IV catheters. 
  • Conduct delegated clinical procedures as required per protocol. 
  • Comply with regulatory requirements, policies, procedures, & standards of practice.  
  • Receipt and proper storage of investigational products   
  • Maintain Investigational Product records in accordance with regulations and sponsor requirements.  
  • Maintain the blinding of all study products where required.    
  • Maintain proper storage, security and temperature for all medications and investigational products.  
  • Maintain appropriate research training and RN licensure in good standing in the province of Clinical Trials activities 

The Expertise Required

• Working knowledge of medical and research terminology  
• Working knowledge of federal regulations, good clinical practices (GCP)  
• Excellent phlebotomy skills 
• Ability to communicate and work effectively with a diverse team of professionals.  
• Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.  
• Ability to work independently in a fast-paced environment with minimal supervision.  
• Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments.  
• Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors.  
• Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.  
• Strong computer skills  
• Ability to balance tasks with competing priorities.  
• Critical thinker and problem solver.  
• Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done.  
• Friendly, outgoing personality; maintain a positive attitude under pressure.  
• High level of self-motivation and energy.  
• Ability to work independently in a fast-paced environment with minimal supervision.  
• Must have a client service mentality.   

How We Work Together

• Location: Cape Breton, Canada
• Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.